When she discovered that some companies have been accused of putting profit over production or distribution of cytarabine and other drugs, she was angry — and she began writing letters.
One of her letters went to Rep. Elijah E. Cummings, the ranking Democrat on the House Oversight and Government Reform Committee, who has since joined a growing list of lawmakers and regulators looking into the shortages of many lifesaving prescription drugs, which have reached record highs in recent years.
After his staff investigated, collecting documents and information from several large-scale pharmaceutical buyers, Cummings now alleges that several companies are selling some drugs on the U.S. Food and Drug Administration's shortage list at huge markups. While not accusing the companies of wrongdoing, he sent his own letters Wednesday to five companies to request more information about the source of their drugs and their profits.
The companies — including one Cummings says is peddling the cancer drug cytarabine for $990 a vial, or 80 times its normal sales price — operate in a "gray market" that neither makes drugs nor treats patients. They are distributors who buy from manufacturers and sell to hospitals and pharmacies, though sometimes they also buy and sell among other distributors.
Cummings' inquiry into the system could lead to price-gouging legislation or other laws to ensure that the product is safe, legally obtained and available.
"Price gouging for drugs that treat cancer in children is simply unconscionable," Cummings said in a statement. "We want to know where these companies are getting these drugs and how much they are making in profits. Obtaining this information will help us develop concrete solutions."
Cytarabine, a chemotherapy drug commonly prescribed for many types of cancer, has been in short supply for about a year, according to the Leukemia and Lymphoma Society. The FDA reports that its three manufacturers blame production delays and high demand.
Cummings wrote to cytarabine distributor Miami-based Allied Medical Supply's chief executive Anthony Minnuto: "Although it is possible that you have higher labor and equipment costs than other distributors, it is difficult to understand why your company would charge over $990 a vial when the normal contract price for the drugs is approximately $12 a vial."
Four other companies got similar letters about some of their products, which are being sold for 20 to 50 times their normal sale prices, according to documents provided to Cummings' office by potential buyers.
One of the companies, Rockville-based Premium Rx National LLC, said it is reviewing the request.
"We intend to make a timely response to this inquiry. As a general rule, we believe secondary wholesalers play an important role in helping health care providers locate needed products during manufacturing shortages," Brian Greenwald, the company's president, said in an email statement.
Dan Herlihy, owner of Columbia-based Premium Health Services, said he would meet with Cummings' staff Wednesday and invited the congressman to tour his family-owned small business. He said he plans to fully cooperate with the investigation and supports a federal "pedigree" law, which would require documentation of a drug's chain of control.
"I look forward to meeting Congressman Cummings to highlight the inefficiencies that have led to the shortages we are facing," Herlihy said in an email statement.
The three other companies did not return calls by The Baltimore Sun seeking comment. If the companies don't respond to Cummings, he could seek to have the information subpoenaed.
Other members of Congress and regulators are also working to address the shortages, which have tripled in the last six years to 178 in 2010 from 61 in 2005, according to the FDA.
Sen. Amy Klobuchar, a Minnesota Democrat, introduced the Preserving Access to Life-Saving Medications Act that would require drugmakers to notify the FDA if they expect a shortage. The FDA would also have to say how it would address shortages and more quickly reinspect plants cited by the agency for quality-control problems.
FDA officials say they are working to import some drugs and get some manufacturing plants back on line faster after they fail safety inspections. But they say bigger problems stem from industry consolidation and discontinuation of less profitable generic drugs.